REDAPT 71352362Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556657874), received between Mar 14, 2023 and Sep 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HIS LEFT THA SYSTEM (UNKNOWN MANUFACTURER) ON (B)(6) 2019 DUE TO SUBSIDENCE OF LEFT FEMORAL STEM. DURING THE REVISION SURGERY, ALL THE SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW SYSTEM COMPOSED BY A SMITH AND NEPHEW REDAPT MODULAR SHELL, AND A REDAPT FEMORAL COMPONENT. AS REPORTED, ON (B)(6) 2019, THE PATIENT SUFFERED FROM FLUID BUILD UP AND LEFT LOWER EXTREMITY SWELLING. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED, BUT IT DID RESULT IN READMISSION OF THE PATIENT TO THE HC FACILITY. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 20196561 ↗
• InjuryMar 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT THA, ONE (1) PATIENT PRESENTED A LOOSE THA SYSTEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2020, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP CONFIRMED A GOOD POSITION WITHOUT DISLOCATION, WEAR NOR EVIDENCE OF FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 16583112 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT HIP THA SECOND REVISION HAD BEEN PERFORMED ON (B)(6)2020 TO EXCHANGE FEMORAL HEAD AND LINER DUE TO AN UNKNOWN DIAGNOSIS, THE PATIENT SUSTAINED LEFT HIP PAIN WITH AMBULATION DIFFICULTIES AND WAS TAKEN TO THE OPERATING ROOM DUE THE CONCERN OF A PROSTHETIC JOINT INFECTION. A TWO-STAGE THIRD REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 (FIRST STAGE) AND ON (B)(6) 2020 (SECOND STAGE) TO TREAT THESE SYMPTOMS. DURING THE FIRST PROCEDURE, AN OSTEOTOMY WAS REQUIRED TO REMOVE THE FEMORAL COMPONENT AND THE FLUID FROM THE HIP JOINT WAS SAMPLED AND CULTURED. AN EXTENSIVE SALINE LAVAGE CONTAINING BACITRACIN AND POLYMYXIN WAS PERFORMED INSIDE THE INTRAMEDULLARY CANAL. THE ACETABULAR CUP WAS ALSO REMOVED WITH A SUBSEQUENT SALINE AND ANTIBIOTIC IRRIGATION. A REDAPT STEM WAS IMPLANTED AND COATED WITH ANTIBIOTIC CEMENT AS NO PRE-MADE ARTICULATING SPACER WAS AVAILABLE. TWO ADDITIONAL BAGS OF ANTIBIOTIC CEMENT WERE MIXED TO PLACE THE 28 MM +0 FEMORAL HEAD TO MAKE A ¿CUSTOM MADE¿ UNIPOLAR HEAD THAT WAS ATTACHED TO THE FEMORAL COMPONENT. CERCLAGE CABLES WERE USED TO SECURE THE FEMORAL OSTEOTOMY FRAGMENT. THE PATIENT WAS AWAKENED AND TRANSPORTED TO THE RECOVERY ROOM IN

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 16542405 ↗